This is a multicenter, double-blind, double-dummy, randomized, active-controlled study that will include an 8-day treatment period followed by a 1-week follow-up period in patients experiencing symptoms of an acute exacerbation of gouty arthritis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
402
indomethacin 50 mg three times a day (TID) for 8 days.
An initial dose of celecoxib 800 mg followed by a second dose of 400 mg 12 hours later on Day 1 (celecoxib 800/400 mg regimen) and continuing 400 mg two times a day (BID) for 7 days.
An initial dose of celecoxib 400 mg followed by a second dose of 200 mg 12 hours later (celecoxib 400/200 mg regimen) and continuing 200 mg two times a day (BID) for 7 days.
Change From Baseline to Day 2 in Patient's Assessment of Pain Intensity
The Patient's Pain Intensity in the Index Joint for the prior 24 hours was assessed by completion of the following 5 point scale: My pain over the past 24 hours has been: None (0), Mild (1), Moderate (2), Severe (3), or Extreme (4).
Time frame: Baseline and Day 2
Change From Baseline in Physician's Assessment of the Index Joint on Days 5, 9, and 14/Early Termination: Tenderness
Tenderness was assessed on the basis of palpation or passive motion using a 4 point scale with the following ratings: the patient had no tenderness (0), the patient complained of pain (1), the patient complained of pain and winced (2) and the patient complained of pain, winced, and withdrew (3).
Time frame: Baseline, Day 5, Day 9, and Day 14/Early Termination
Change From Baseline in Physician's Assessment of the Index Joint on Days 5, 9, and 14/Early Termination: Swelling
Swelling was assessed using a 4 point scale with the following ratings: none (0), palpable (1), visible (2), and bulging beyond joint margins (3)
Time frame: Baseline, Days 5, 9 and 14/Early Termination
Number of Participants With Redness Present According to Physician's Assessment of the Index Joint on Day 5, Day 9, and Day 14/Early Termination
Redness was assessed by the physician as present or absent.
Time frame: Baseline, Day 5, Day 9 and Day 14/Early Termination
Number of Participants With Warmth Present According to Physician's Assessment of the Index Joint on Day 5, Day 9, and Day 14
Warmth was assessed by the physician as present or absent.
Time frame: Baseline, Day 5, Day 9 and Day 14
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Celecoxib 50 mg two times a day (BID) for 8 days
Pfizer Investigational Site
Glendale, Arizona, United States
Pfizer Investigational Site
Mesa, Arizona, United States
Pfizer Investigational Site
Paradise Valley, Arizona, United States
Pfizer Investigational Site
Peoria, Arizona, United States
Pfizer Investigational Site
Roseville, California, United States
Pfizer Investigational Site
San Diego, California, United States
Pfizer Investigational Site
San Luis Obispo, California, United States
Pfizer Investigational Site
Longmont, Colorado, United States
Pfizer Investigational Site
Northglenn, Colorado, United States
Pfizer Investigational Site
DeLand, Florida, United States
...and 71 more locations
Change From Baseline in Patient's Assessment of Pain Intensity
The Patient's assessment of pain for the prior 24 hours was assessed by completion of the following 5 point scale: My pain over the past 24 hours has been: None (0), Mild (1), Moderate, (2), Severe (3), and Extreme (4).
Time frame: Baseline, Day 2 to Day 13
Change From Baseline in Patient's Assessment of Pain Intensity on Day 1
The patient's assessment of pain was assessed by completion of the following 5 point scale: my pain at this time is none (0), mild (1), moderate, (2), severe (3), and extreme (4).
Time frame: Baseline, 2, 4, 8, 12 hours postdose Day 1, Day 2 (24 hours and 32 hours post first dose)
Change From Baseline in Time Weighted Average of Patient's Assessment of Pain Intensity Over 8, 12, and 24 Hours
Time weighted average over 8 (TWA-8), 12 (TWA-12) and 24 (TWA-24) hours post first dose of study medication on Day 1. Positive TWA values represent a reduction in pain intensity
Time frame: Baseline, 8, 12, and 24 hours post first dose
Number of Participants With ≥30% and ≥50% Reduction From Baseline to Day 2 in Patient's Assessment of Pain Intensity
The Patient's assessment of pain was assessed by completion of the following 5 point scale: My pain over the past 24 hours has been: None (0), Mild (1), Moderate, (2), Severe (3), and Extreme (4).
Time frame: Baseline, Day 2
Participant's Assessment of Pain Intensity for the Average Pain Intensity at Baseline
The participant's assessment of pain was assessed by completion of the following 5 point scale: My pain has been: None (0), Mild (1), Moderate, (2), Severe (3), and Extreme (4).
Time frame: Baseline
Percentage Change From Baseline in the Patient's Assessment of Pain Intensity for the Average Pain Intensity on Days 2-4, Days 2-8 and Days 2-13
The participant's assessment of pain was assessed by completion of the following 5 point scale: My change in pain has been: None (0), Mild (1), Moderate, (2), Severe (3), and Extreme (4). Average change over days was calculated by taking the change from Baseline to the average Pain Intensity score over the days for each patient.
Time frame: Baseline to Day 13
Number of Participants With Withdrawal From Treatment Due to Lack of Efficacy
Withdrawal due to lack of efficacy was assessed from Days 1 to 8
Time frame: Day 1 to Day 8
Participants Global Evaluation of Study Medication Score
The participant rated the study medication that they received during the study by completing the following question: How would you rate the study medication you received for pain? 4=Excellent, 3=Good, 2=Fair, 1=Poor
Time frame: Day 9
Number of Participants With Pre-specified Gastrointestinal (GI) Adverse Events
The gastrointestinal tolerability was measured by incidence of moderate or severe GI adverse events (nausea, abdominal pain and dyspepsia)
Time frame: Baseline to Day 14/Early Termination
Number of Participants With Moderate or Severe Central Nervous System (CNS) Adverse Events
The pre-specfied CNS AEs were headache, nausea, dizziness, vertigo, vomiting and somnolence.
Time frame: Baseline to Day 14/Early Termination